ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease
About this study
The purpose of this study is to evaluate the safety and efficacy of the ExAblate Model 4000 Type 2.0 System as a tool to disrupt the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).
- Condition
- Alzheimer Disease
- Tested
- Blood Brain Barrier (BBB) Disruption
- Sponsor
- InSightec
Who can join
- Age
- 50 to 85 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 50 years
- Maximum age: 85 years
- Study condition: Alzheimer Disease
- Male or Female between 50-85 years of age
- Probable Alzheimer's Disease (AD)
- If taking concurrent Alzheimer's medication, has been on the medication for at least 2 months with a stable dose for at least 3 months
- Able to communicate sensations during the ExAblate MRgFUS procedure
- Ambulatory
Exclusion 17
- MRI Findings
- Presence of unknown or MR unsafe devices anywhere in the body
- Significant cardiac disease or unstable hemodynamic status
- Relative contraindications to ultrasound contrast agent or PET amyloid tracer
- History of a bleeding disorder
- History of liver disease
- Known cerebral or systemic vasculopathy
- Significant depression and at potential risk of suicide
- Any contraindications to MRI scanning
- Any contraindication to lumbar puncture for collection of cerebral spinal fluid
- Untreated, uncontrolled sleep apnea
- History of seizure disorder or epilepsy
- Severely Impaired renal function
- Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research
- Chronic pulmonary disorders
- Positive human immunodeficiency virus (HIV)
- Known apolipoprotein E allele (ApoE4) homozygosity
Where
10 sites, 6 recruiting
Delray Medical Center & Florida Atlantic University
Delray Beach, Florida, United States
Broward Health Medical Center & The University of Florida
Fort Lauderdale, Florida, United States
University of Florida Health Shands
Gainesville, Florida, United States
Baptist Health South Florida & Florida International University
Miami, Florida, United States
Advent Health
Orlando, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
and 4 more sites on ClinicalTrials.gov
Potential match only. Final eligibility is determined by the study team.